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ALENDRONATE SODIUM

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Alendronate Sodium Adverse Events Reported to the FDA Over Time

How are Alendronate Sodium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Alendronate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Alendronate Sodium is flagged as the suspect drug causing the adverse event.

Most Common Alendronate Sodium Adverse Events Reported to the FDA

What are the most common Alendronate Sodium adverse events reported to the FDA?

Femur Fracture
2153 (6.97%)
Low Turnover Osteopathy
903 (2.92%)
Stress Fracture
714 (2.31%)
Bone Disorder
707 (2.29%)
Fall
619 (2%)
Arthralgia
404 (1.31%)
Fracture
340 (1.1%)
Pain In Extremity
332 (1.07%)
Anxiety
300 (.97%)
Pain
266 (.86%)
Osteoarthritis
261 (.84%)
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Impaired Healing
250 (.81%)
Tooth Disorder
211 (.68%)
Hypertension
209 (.68%)
Back Pain
203 (.66%)
Gastrooesophageal Reflux Disease
203 (.66%)
Depression
177 (.57%)
Osteoporosis
172 (.56%)
Gait Disturbance
166 (.54%)
Hyperlipidaemia
164 (.53%)
Anaemia
154 (.5%)
Oedema Peripheral
147 (.48%)
Nausea
146 (.47%)
Osteonecrosis
145 (.47%)
Osteomyelitis
143 (.46%)
Foot Fracture
142 (.46%)
Myalgia
138 (.45%)
Fatigue
134 (.43%)
Device Failure
132 (.43%)
Vitamin D Deficiency
129 (.42%)
Multiple Fractures
126 (.41%)
Chest Pain
123 (.4%)
Arthropathy
122 (.39%)
Fracture Nonunion
121 (.39%)
Diarrhoea
117 (.38%)
Constipation
115 (.37%)
Pathological Fracture
115 (.37%)
Bone Density Decreased
112 (.36%)
Emotional Distress
110 (.36%)
Spinal Osteoarthritis
110 (.36%)
Adverse Drug Reaction
108 (.35%)
Headache
107 (.35%)
Insomnia
106 (.34%)
Intervertebral Disc Degeneration
103 (.33%)
Urinary Tract Infection
102 (.33%)
Dental Caries
100 (.32%)
Dyspnoea
99 (.32%)
Arthritis
97 (.31%)
Osteogenesis Imperfecta
97 (.31%)
Fear Of Disease
96 (.31%)
Intervertebral Disc Protrusion
96 (.31%)
Muscle Spasms
96 (.31%)
Asthenia
95 (.31%)
Drug Hypersensitivity
94 (.3%)
Chronic Obstructive Pulmonary Disea...
92 (.3%)
Bursitis
91 (.29%)
Cataract
88 (.28%)
Dizziness
86 (.28%)
Haemorrhagic Anaemia
83 (.27%)
Blood Cholesterol Increased
82 (.27%)
Cellulitis
82 (.27%)
Exostosis
82 (.27%)
Dysphagia
80 (.26%)
Haemorrhoids
80 (.26%)
Rash
80 (.26%)
Osteopenia
79 (.26%)
Jaw Disorder
78 (.25%)
Hypercholesterolaemia
77 (.25%)
Joint Swelling
77 (.25%)
Weight Decreased
77 (.25%)
Anhedonia
75 (.24%)
Quality Of Life Decreased
75 (.24%)
Asthma
74 (.24%)
Pyrexia
74 (.24%)
Anaemia Postoperative
72 (.23%)
Cough
71 (.23%)
Rotator Cuff Syndrome
71 (.23%)
Hip Fracture
70 (.23%)
Pneumonia
70 (.23%)
Tooth Extraction
70 (.23%)
Bone Pain
69 (.22%)
Bronchitis
67 (.22%)
Musculoskeletal Pain
67 (.22%)
Drug Ineffective
66 (.21%)
Pain In Jaw
66 (.21%)
Urinary Incontinence
66 (.21%)
Oral Infection
65 (.21%)
Vomiting
65 (.21%)
Abdominal Pain Upper
64 (.21%)
Muscular Weakness
64 (.21%)
Oesophagitis
64 (.21%)
Hypothyroidism
63 (.2%)
Rib Fracture
63 (.2%)
Adverse Event
62 (.2%)
Hypokalaemia
62 (.2%)
Oral Disorder
62 (.2%)
Sciatica
61 (.2%)
Paraesthesia
60 (.19%)
Ankle Fracture
59 (.19%)
Toothache
58 (.19%)
Contusion
57 (.18%)

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This graph shows the top adverse events submitted to the FDA for Alendronate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alendronate Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Alendronate Sodium

What are the most common Alendronate Sodium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Alendronate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alendronate Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Alendronate Sodium According to Those Reporting Adverse Events

Why are people taking Alendronate Sodium, according to those reporting adverse events to the FDA?

Osteoporosis
4112
Drug Use For Unknown Indication
1006
Osteopenia
996
Product Used For Unknown Indication
628
Osteoporosis Prophylaxis
525
Prophylaxis
199
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Bone Disorder
161
Rheumatoid Arthritis
93
Bone Density Decreased
57
Osteoporosis Postmenopausal
47
Osteoarthritis
38
Hypercalcaemia
31
Mineral Supplementation
24
Bone Density Abnormal
21
Metastases To Bone
19
Spinal Fracture
19
Resorption Bone Increased
18
Osteoporotic Fracture
16
Spinal Compression Fracture
14
Bone Loss
14
Ill-defined Disorder
13
Osteonecrosis
12
Postmenopause
10
Polymyalgia Rheumatica
9
Supplementation Therapy
9
Back Pain
9
Arthritis
8
Multiple Myeloma
8
Adverse Drug Reaction
7
Breast Cancer
7
Systemic Lupus Erythematosus
6
Pain
6
Musculoskeletal Pain
6
Spinal Column Stenosis
6
Osteogenesis Imperfecta
5
Osteitis Deformans
5
Prostate Cancer
5
Calcium Deficiency
5
Fracture
4
Crohns Disease
4
Bone Scan
3
Blood Calcium Abnormal
3
Hip Fracture
3
Peritonitis
3
Psoriatic Arthropathy
3
Disease Complication
3
Cancer Pain
2
Idiopathic Thrombocytopenic Purpura
2
Pelvic Fracture
2
Organ Transplant
2
Osteolysis
2

Drug Labels

LabelLabelerEffective
Alendronate SodiumSUN PHARMA GLOBAL INC.11-APR-09
Alendronate SodiumCobalt Laboratories Inc.28-OCT-09
Alendronate SodiumDispensing Solutions Inc.28-JAN-10
Alendronate SodiumRebel Distributors Corp26-JAN-11
Alendronate SodiumCobalt Laboratories Inc.27-APR-11
Alendronate SodiumUDL Laboratories, Inc.06-MAY-11
Alendronate SodiumWatson Laboratories, Inc.21-JUL-11
Fosamax Plus DPhysicians Total Care, Inc.20-DEC-11
Alendronate Sodium Jubilant Cadista Pharmaceuticals Inc.01-FEB-12
Fosamax Plus DMerck Sharp & Dohme Corp.29-FEB-12
Alendronate SodiumApotex Corp.10-APR-12
Alendronate SodiumPhysicians Total Care, Inc.24-APR-12
Alendronate SodiumAmerican Health Packaging22-JUN-12
BinostoMission Pharmacal Company26-JUN-12
FosamaxMerck Sharp & Dohme Corp.27-JUN-12
Alendronate SodiumAurobindo Pharma Limited02-AUG-12
Alendronate SodiumAscend Laboratories, LLC14-AUG-12
Alendronate SodiumMylan Pharmaceuticals Inc.31-AUG-12
Alendronate SodiumNorthStar Rx LLC06-NOV-12
Alendronate SodiumTeva Pharmaceuticals USA Inc20-DEC-12
Alendronate SodiumBlu Pharmaceuticals, LLC31-JAN-13
Alendronate SodiumApotex Corp.01-FEB-13
FosamaxMerck Sharp & Dohme Corp.19-APR-13
Fosamax Plus DMerck Sharp & Dohme Corp.19-APR-13

Alendronate Sodium Case Reports

What Alendronate Sodium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Alendronate Sodium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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